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Clinical Investigations: PULMONARY |

Ciclesonide, a Novel Inhaled Steroid, Does Not Affect Hypothalamic-Pituitary-Adrenal Axis Function in Patients With Moderate-to-Severe Persistent Asthma*

Stanley Szefler, MD; Shashank Rohatagi, PhD, MBA; James Williams, MD; Mark Lloyd, BS; Sudeep Kundu, PhD; Donald Banerji, MD
Author and Funding Information

*From the National Jewish Medical & Research Center (Dr. Szefler), Denver, CO; and Aventis Pharmaceuticals, a member of the Sanofi-Aventis Group (Drs. Rohatagi, Kundu, and Banerji, and Mr. Lloyd), Bridgewater, NJ.

Correspondence to: Stanley J. Szefler, MD, National Jewish Medical & Research Center, 1400 Jackson St, Room J313, Denver, CO 80206; e-mail: szeflers@njc.org



Chest. 2005;128(3):1104-1114. doi:10.1378/chest.128.3.1104
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Background: Inhaled corticosteroids (ICSs) reduce local airway inflammation, which is an underlying cause of asthma symptoms. However, potential systemic side effects associated with ICS use are a major concern for asthmatic patients.

Methods: Adult patients (n = 60; ≥ 18 years of age) with moderate-to-severe asthma were randomized to receive 4 weeks of treatment with ciclesonide (CIC), 320 μg bid (CIC 640), CIC, 640 μg bid (CIC 1280), fluticasone propionate (FP), 440 μg bid (FP 880), FP 880 μg bid (FP 1760), or placebo (PBO) [all doses expressed as ex-actuator; comparable to ex-valve doses of 800 and 1,600 μg/d for CIC and 1,000 and 2,000 μg/d for FP, respectively].

Results: After 29 days of treatment, CIC 640, CIC 1280, and FP 880 had no significant effect on the mean serum cortisol area under the curve for 0 to 24 h (AUC0–24h). FP 1760 produced a statistically significant suppression in mean serum cortisol AUC0–24h compared to PBO (p = 0.0009; 95% confidence interval [CI], = 117.5 to −32.1). Results obtained with cosyntropin stimulation revealed no statistically significant differences among the groups. The CIC 640 group demonstrated a significant increase compared to the PBO group in 24-h urinary cortisol levels from baseline at week 4 (p = 0.0224; 95% CI, 0.0023 to 0.0283), while the other treatment groups revealed no change in this parameter. The incidence of treatment-emergent adverse events was similar in all groups, and all adverse events were mild or moderate in severity.

Conclusion: Treatment with moderate and high doses of CIC does not result in hypothalamic-pituitary-adrenal-axis suppression as compared with PBO.

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